Medical device recalls Moderate risk

Terumo Cardiovascular Systems Corporation recalls Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

Recall date
June 14, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2102-2019
FDA classification
Class II
Brand / firm
Terumo Cardiovascular Systems Corporation
Sold / distributed
MI Foreign: Japan, Belgium

Why it was recalled

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW

Get recall alerts

Free email alert whenever Terumo Cardiovascular Systems Corporation has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Terumo Cardiovascular Systems Corporation